The FDA has given its blessing to Jazz Pharmaceuticals’ bispecific antibody Ziihera, allowing its use in newly diagnosed patients with gastroesophageal adenocarcinoma.
In particular, Ziihera is now indicated as a first-line treatment for patients with unresectable locally advanced or metastatic gastroesophageal adenocarcinoma (GEA) who harbor HER2 mutations, according to a Tuesday release. Ziihera is meant to be used with or without BeOne Medicines’ Tevimbra on top of chemotherapy.
Analysts at Truist Securities were unsurprised by the approval, calling the decision “anticipated” in a Tuesday note to investors. Still, the firm is encouraged by the verdict, saying that it “de-risks the largest piece of our Ziihera build for JAZZ.”